Scientist, Analytical Development

Overview

Alnylam is the world's leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with three approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,500 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe's Top Places to Work six years in a row (2015-2020), a Great Place to Work in the U.K. and Switzerland two years in a row (2019-2020) and a Science Magazine's Top Employer two years in a row (2019-2020). Please visit www.alnylam.com for more information.

The Scientist, Analytical Development will be responsible for qualification of reference materials and providing analytical support to Process Development and Toxicology groups using a variety of analytical techniques. The scientist will be responsible for executing analytical testing of siRNA drug substance, drug product, and related materials to enable non-clinical studies, and will also support the qualification and characterization of reference materials used within Analytical Development for early-stage programs, ensuring continuous supply and life cycle management of reference materials throughout the organization.

Summary of Key Responsibilities

• Performs complex testing and sophisticated data analysis of in-process and final formulation siRNA drug substance and drug product and related materials utilizing the following analytical techniques: LC/UV and LC/MS assays, osmolality, LAL endotoxin assay, UV/VIS, Tm and pH. Oversees the resolution of testing problems with minimal supervision.
• Execute analytical qualification activities for early phase reference materials including authoring of protocols and reports
• Author and/or review Certificates of Testing for critical siRNA as needed
• Provide technical support for Toxicology by performing dosing concentration analyses and authoring reports
• Perform critical molar absorptivity determinations for early phase program single strand intermediates and drug substances.
• Evaluate new technologies and method improvements as needed
• Train staff members on relevant analytical techniques as needed
• Must exhibit excellent leadership, interpersonal and teamwork skills
• Manages multiple tasks and competing priorities effectively, with a focused attention to detail
• Shows flexibility and helps define appropriate testing schedules for multiple programs

Qualifications

• Master's or Bachelor's degree with > 5 years or > 10 years biopharmaceutical experience respectively, with demonstrated chromatographic separation and structure elucidation expertise.
• Strong knowledge of fundamental liquid phase chromatographic separation mechanisms, proven years of excellent hands-on method development and optimization experience on HPLC, UPLC and LC/MS for separation of siRNA.
• Self-motivated, excellent communication, writing and reviewing skills.
• Familiarity with Waters and Agilent (U)HPLC hardware. Familiarity with Empower, Chemstation are preferred.
• Familiarity with cGMP, ICH and regulatory guidelines is a plus.
• Experience with oligonucleotide assays is preferred.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.